Citations 1
Application, Verification, and Implementation of SARS-CoV-2 Serologic Assays with Emergency Use Authorization
Theel, Elitza S. , Couturier, Marc Roger , Filkins, Laura , Palavecino, Elizabeth , Mitchell, Stephanie L. , Campbell, Sheldon , Pentella, Michael , Butler‐Wu, Susan M. , Jerke, Kurt, Dharmarha, Vaishali, McNult, Peggy, Mitchell, Stephanie , Butler-Wu, Susan , Schuetz, Audrey N , Schuetz, Audrey N.
Journal of Clinical Microbiology | October 6, 2020 | Volume: 59 | Issue: 1 | Pages: No page available
Interest continues to grow regarding the role of serologic assays for the detection of prior infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) status to many SARS-CoV-2 serologic assays. In this document, expert recommendations from clinical microbiologist members of the American Society for Microbiology (ASM) concerning detailed verification strategies for SARS-CoV-2 serologic assays with FDA EUA are provided, as are insights into assay limitations and reporting considerations for laboratories.